Levofloxacin Hemihydrate NEW

Levofloxacin Hemihydrate Cas 138199-71-0

Specification

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Levofloxacin hemihydrate is the specific crystalline form of the antibiotic drug levofloxacin, where each molecule of levofloxacin is associated with half a molecule of water (i.e., a 2:1 ratio of levofloxacin to water). Its chemical formula is often written as C₁₈H₂₀FN₃O₄·½H₂O.

• Levofloxacin itself is a synthetic fluoroquinolone antibiotic. It is the optically active L-isomer of ofloxacin, which gives it greater antibacterial potency.

  Hemihydrate refers to its solid-state form, a key aspect in pharmaceutical chemistry that influences properties like stability, solubility, and manufacturability.

Primary (Medical) Use

Its primary use is as a broad-spectrum antibacterial agent. It works by inhibiting bacterial DNA gyrase and topoisomerase IV enzymes, essential for DNA replication. It is used to treat infections such as:

• Pneumonia

  Sinus infections

  Urinary tract infections (UTIs)

  Skin infections

  Chronic bronchitis

Uses in Chemical and Pharmaceutical Contexts

In the realm of chemistry (particularly pharmaceutical chemistry and process chemistry), levofloxacin hemihydrate is significant for the following reasons:

1. Solid Form Selection and Polymorphism

• Objective: To identify the most thermodynamically stable and pharmaceutically acceptable crystalline form of the active pharmaceutical ingredient (API).

  Role: The hemihydrate is the preferred commercial form of levofloxacin. Chemists work to ensure consistent crystallization to this form, as different hydrates or polymorphs can have varying solubilities, dissolution rates, and stability, which directly impact drug efficacy and shelf life.

2. Process Chemistry & Scale-up

• Synthesis: Chemical engineers and process chemists develop and optimize the multi-step synthetic route to produce levofloxacin, culminating in the final step where the hemihydrate is crystallized.

  Crystallization Engineering: The precise control of conditions (solvent, temperature, cooling rate, water activity) to reliably produce the hemihydrate on an industrial scale is a critical chemical operation.

3. Analytical Chemistry & Quality Control (QC)

• Characterization: Chemists use techniques like:

• X-ray Powder Diffraction (XRPD): To confirm the unique crystalline pattern of the hemihydrate.

  Thermogravimetric Analysis (TGA) / Differential Scanning Calorimetry (DSC): To measure the precise water content and melting point, distinguishing it from the anhydrous form or other hydrates.

  Karl Fischer Titration: To quantitatively determine the water content (theoretical ~1.8% for the hemihydrate).

  HPLC: To assay chemical purity and potency.

• QC Testing: Every batch manufactured must be rigorously tested to confirm its identity as the hemihydrate and to ensure it meets purity specifications.

4. Formulation Development

• Compatibility: Chemical studies assess how the levofloxacin hemihydrate interacts with excipients (fillers, binders) in tablets or IV solutions.

  Stability Studies: Chemists monitor the chemical stability of the hemihydrate form under various conditions (heat, humidity, light) to define storage requirements and shelf life. A key concern is preventing unwanted phase transformations.

5. Intellectual Property & Regulatory Filings

• The specific hemihydrate form is a definable chemical entity. Its characterization data, manufacturing process, and stability profile are critical components of regulatory dossiers (e.g., to the FDA or EMA). Patent protection often specifically claims the hemihydrate form.

Key Chemical Property: Hydrate Stability

The "hemihydrate" nature is its defining chemical feature. The water molecules are incorporated into the crystal lattice. This form is typically chosen because:

• It is less hygroscopic than an amorphous form.

  It often has better chemical and physical stability than the anhydrous form under typical storage conditions.

  It provides a reproducible dissolution profile, which is crucial for consistent drug absorption.

Summary

While levofloxacin hemihydrate is clinically an antibiotic, from a chemical perspective, it is:

• A case study in solid-state chemistry and polymorphism.

  The target output of an optimized chemical synthesis and crystallization process.

  The subject of extensive analytical characterization for quality assurance.

  A key factor in pharmaceutical formulation and stability.

Its "uses in chemistry" are therefore centered around its development, manufacturing, analysis, and control as a stable, effective, and reproducible active pharmaceutical ingredient (API).

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